# K072968: Stressgard Nightguard

- Pathway: 510(k) (Traditional)
- Applicant: Totalgard Corporation
- Decided: Jul 1, 2008 after 253 days
- Product code: OBR (Mouthguard, Over-The-Counter)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K022809 (2003). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053580: Doctor's Nightguard, Dental Concepts, LLC (2006) Summary page 2.
- K072147: Den Tek Comfort Fit Nightguard, Den Tek Oral Care, Inc. (2007) Summary page 2.
- K071404: Sleep Right - Select, Low Profile and Advance, Power Products, Inc.-Splintek (2007) Summary page 2.

## Indications for use
The StressgardTM Night Guard is indicated for protection from night-time teeth grinding, clenching and bruxism. It is intended to reduce damage to teeth and to prevent the noise associated with teeth grinding or bruxing.

Source page: https://510kreport.com/device/K072968
Methodology: https://510kreport.com/methodology